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Measuring Quality of Decisions About Treatment of Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01152307
Recruitment Status : Completed
First Posted : June 29, 2010
Results First Posted : August 20, 2012
Last Update Posted : August 20, 2012
Sponsor:
Collaborators:
Foundation for Informed Medical Decision Making
Massachusetts General Hospital
Information provided by (Responsible Party):
Carol Cosenza, University of Massachusetts, Boston

Tracking Information
First Submitted Date  ICMJE June 22, 2010
First Posted Date  ICMJE June 29, 2010
Results First Submitted Date  ICMJE June 12, 2012
Results First Posted Date  ICMJE August 20, 2012
Last Update Posted Date August 20, 2012
Study Start Date  ICMJE June 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2012)
Depression Knowledge [ Time Frame: 2 weeks, on average ]
Total knowledge score from factual questions about depression and methods for managing depression symptoms. Score is the percent of knowledge items answered correctly (0 - 100%).
Original Primary Outcome Measures  ICMJE
 (submitted: June 25, 2010)
Knowledge [ Time Frame: 2 weeks, on average ]
Total knowledge score from factual questions about depression and methods for managing depression symptoms
Change History Complete list of historical versions of study NCT01152307 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2010)
Value Concordance [ Time Frame: 2 weeks, on average ]
Measure of how concordant respondents' actual decisions about treatment for their depression are with their stated beliefs
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Measuring Quality of Decisions About Treatment of Depression
Official Title  ICMJE Measuring Quality of Decisions About Treatment of Depression
Brief Summary The purpose of this randomized controlled trial is to examine the impact of a patient decision aid on the quality of decisions about managing symptoms of depression. In particular, we will examine whether the decision aid increases knowledge about depression/managing depression symptoms and concordance between goals and treatment choices.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Depression
Intervention  ICMJE Behavioral: DVD/Booklet: Coping with Symptoms of Depression
DVD and booklet that provides information about treatment choices for depression symptoms
Other Names:
  • Decision aids
  • Shared decision making programs
Study Arms  ICMJE
  • Experimental: Decision Aid
    Group receiving the decision aid (DVD/booklet)
    Intervention: Behavioral: DVD/Booklet: Coping with Symptoms of Depression
  • No Intervention: Control
    Group not receiving the decision aid (DVD/booklet)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2012)
405
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2010)
900
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 18+
  • In the last 12 months, talked to a health care provider about starting or stopping a treatment (prescription medicine for depression or counseling)

Exclusion Criteria:

  • none
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01152307
Other Study ID Numbers  ICMJE CSR-DQ1-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carol Cosenza, University of Massachusetts, Boston
Study Sponsor  ICMJE University of Massachusetts, Boston
Collaborators  ICMJE
  • Foundation for Informed Medical Decision Making
  • Massachusetts General Hospital
Investigators  ICMJE
Study Director: Patricia M Gallagher, PhD Center for Survey Research/University of Massachusetts Boston
Principal Investigator: Karen R Sepucha, PhD Massachusetts General Hospital
PRS Account University of Massachusetts, Boston
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP